Envarsus XR in African American Renal Transplant Recipients (EXR)

The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.

African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.

The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization

Study Overview

• Status: Terminated
• Conditions: Renal Transplant Recipients
• Intervention / Treatment: Drug: ENVARSUS®

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Medstar Georgetown Transplant Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. African American race
2. Adult renal transplant recipients (>18 y/o)
3. Previous adverse reaction or contraindication to the use of tacrolimus

Exclusion Criteria:

1. Non African American race
2. Less than 18 y/o (pediatric patients)
3. Recipients of liver and small bowel transplants
4. Adverse reaction to tacrolimus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Envarsus; Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL	Drug: ENVARSUS®; ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant; Other Names: Extended Release Tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies.	Data not collected - study terminated prematurely when PI left institution.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal Function After Transplantation	Data not collected - study terminated prematurely when PI left institution.	1 year

Collaborators and Investigators

• Sponsor: Georgetown University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: EXR1